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High RiskFDA
Medtronic Minimed, Inc.
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Diabetes Devices·8,986 affected·Mar 4, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respirat...
Respiratory Devices·442,296 affected·Mar 4, 2025
High RiskFDA
Cordis Us Corp
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Medical Implants·20 affected·Mar 4, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 24T Model/Catalog Number: 427-000 Software Version: N/A Produ...
Diagnostic Devices·592,320 affected·Mar 4, 2025
High RiskFDA
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-000 Software Version: N/A Product Des...
Medical Devices·2,164,872 affected·Mar 4, 2025
High RiskFDA
Medtronic Neuromodulation
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118)...
Medical Devices·1,493 affected·Mar 4, 2025
CriticalFDA
Zoll Circulation, Inc.
Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT Platform Model/Catalog Number: Model 200 (Catalog Number: 87...
Medical Devices·91 affected·Mar 4, 2025
RecallFDA
U.s. Tov, Inc. Dba U.s. Trading Company
DRIED LILY FLOWERS Net Weight 2.5 oz (70g) Ingredients: Lily flower (Hemerocallis citrina) Distributed by: U.S. TRADING COMPANY Hayward, ...
Food·5,200 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
Medical Devices·6 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model ...
Medical Devices·1,098 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Refer to RES
Medical Devices·11,889 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
Medical Devices·48 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, M...
Medical Devices·530 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ84116A
Medical Devices·60 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PAC...
Medical Devices·21,935 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56...
Medical Devices·573 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
Medical Devices·116 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: ...
Medical Devices·706 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Numb...
Medical Implants·354 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
Medical Devices·48 affected·Mar 3, 2025
High RiskFDA
Zimmer Orthopedics Manfacturing Limited-galway
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606...
Medical Implants·90 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
Medical Devices·8 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, M...
Medical Devices·222 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Mo...
Medical Devices·2,118 affected·Mar 3, 2025
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Respiratory Devices·37 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF,...
Medical Devices·3,808 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Numb...
Medical Devices·4,094 affected·Mar 3, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514;...
Medical Devices·9,216 affected·Mar 3, 2025
CriticalFDA
Little Leaf Farms Llc
Little Leaf Farms brand Southwest Salad Kit; 7.5 oz, clear plastic clamshell; UPC: 857394006220
Produce·576 affected·Feb 28, 2025
High RiskFDA
Optima Foods, Inc.
Domna's Bakery 24 PC Baklava Tray 330043 8
Food·8 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharm...
Oral Drugs·18,696 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Phar...
Oral Drugs·84,048 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufa...
Oral Drugs·100 affected·Feb 28, 2025
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by:...
Oral Drugs·100 affected·Feb 28, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barce...
Oral Drugs·11,125 affected·Feb 28, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc...
Oral Drugs·14,749 affected·Feb 28, 2025
High RiskFDA
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc...
Oral Drugs·11,100 affected·Feb 28, 2025
High RiskFDA
Sigan Industries Group Inc.
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, De...
Drugs·13,440 affected·Feb 28, 2025
High RiskFDA
Stryker Spine
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Medical Implants·56 affected·Feb 28, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16241
Medical Devices·122 affected·Feb 28, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Medical Devices·1 affected·Feb 28, 2025
High RiskFDA
Reichert, Inc.
Phoroptor VRx Digital Refraction System Model Numbers: 16242
Medical Devices·1,876 affected·Feb 28, 2025
High RiskFDA
Stryker Spine
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Medical Implants·64 affected·Feb 28, 2025
High RiskFDA
Uncle Rays, Llc
Coyote Valley Sour Cream & Onion Chips, Net Wt. 5oz, UPC 744234810775, Item # 8014265, Food Express USA, Dallas, TX 75261
Dairy·3,005 affected·Feb 27, 2025
High RiskFDA
Amgen, Inc.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solu...
Injectable Drugs·313,620 affected·Feb 27, 2025
High RiskFDA
Amgen, Inc.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use...
Injectable Drugs·258,750 affected·Feb 27, 2025
CriticalFDA
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology
Diabetes Devices·63 affected·Feb 27, 2025
High RiskFDA
Beckman Coulter, Inc.
Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Diagnostic Devices·10,000 affected·Feb 27, 2025